Trials / Withdrawn
WithdrawnNCT03628053
Tisagenlecleucel vs Blinatumomab or Inotuzumab for Patients With Relapsed/Refractory B-cell Precursor Acute Lymphoblastic Leukemia
Tisagenlecleucel Versus Blinatumomab or Inotuzumab for Adult Patients With Relapsed/Refractory B-cell Precursor Acute Lymphoblastic Leukemia: A Randomized Open Label, Multicenter, Phase III Trial
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This trial aims to compare the benefits and risks of tisagenlecleucel to blinatumomab or inotuzumab in adult patients with relapsed or refractory ALL. This trial investigates tisagenlecleucel as an additional treatment option for this patient population with high unmet medical need.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Tisagenlecleucel | autologous cellular immunotherapy product |
| DRUG | Blinatumomab | bispecific CD19-directed CD3 T-cell engager |
| DRUG | Inotuzumab | CD22-directed antibody-drug conjugate |
Timeline
- Start date
- 2020-06-05
- Primary completion
- 2025-10-08
- Completion
- 2026-01-07
- First posted
- 2018-08-14
- Last updated
- 2020-07-09
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03628053. Inclusion in this directory is not an endorsement.